Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
- Conditions
- Leukemia, Lymphocytic, AcuteLeukemiaAcute Lymphoid Leukemia (ALL)
- Interventions
- Drug: Human mAb 216
- Registration Number
- NCT00313053
- Lead Sponsor
- Clare Twist
- Brief Summary
This is a phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- Patients must be > than 12 months at the time of study entry.
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Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.
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For patients WITHOUT prior allogeneic bone marrow transplant (BMT):
- Second or subsequent bone marrow relapse
- Primary refractory marrow disease
- M3 marrow (> 25% blasts)
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For patients WITH prior allogeneic BMT:
- First or subsequent bone marrow relapse post-BMT
- M3 marrow or M2 (> 5% and < 25% blasts) if cytogenetic or variable number tandem repeat (VNTR) confirmation
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Confirmation of antibody reactivity
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Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab).
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Patient's red blood cell (RBC) documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab)
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Patient must not be eligible for therapies of higher priority
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Performance level Karnofsky 50% for patients > 10 years of age and Lansky >= 50 for patients <= 10 years of age.
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Life expectancy must be at least 8 weeks.
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Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study:
- Myelosuppressive chemotherapy: must not have been received within 2 weeks of entry onto this study.
- Biologic: at least 7 days since the completion of therapy with a biologic agent.
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No hematologic criteria for white blood cell (WBC), hemoglobin (Hgb), or platelets
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Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.
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Adequate renal function defined as: a serum creatinine that is less than or equal to 1.5 x normal for age
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Adequate liver function defined as: total bilirubin <= 1.5 x upper limit of normal (ULN) for age, and SGPT (ALT) <= 5 x upper limit of normal (ULN) for age
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Adequate cardiac function defined as: shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study.
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All patients and/or their parents or legal guardians must sign a written informed consent/assent.
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All Institutional Review Board (IRB) and Food and Drug Administration (FDA) requirements for human studies must be met.
- Central nervous system (CNS) 3 or refractory CNS leukemia
- Isolated extramedullary relapse
- Uncontrolled infection
- Lack of mAb 216 binding to patient's leukemic blasts in vitro
- Binding of mAb 216 to the"i" antigen on patient's erythrocytes
- Prior treatment with rituximab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Human mAb 216 Human mAb 216 - Human mAb 216 Vincristine -
- Primary Outcome Measures
Name Time Method Maximum tolerable dose without toxicity Safety
- Secondary Outcome Measures
Name Time Method Decrease in leukemic blasts
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States